EXP. Date 09/ 30/ 2007
PUBLIC Disclosure Burden Statement
Public reporting burden for this collection of information is estimated to average 45 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: “
FDA Form 3670
User Facility Name: _______________________________
Address: _______________________________
_______________________________
_______________________________
Contact Name: _______________________________
Contact Phone #: ( ) _____________
Contact Fax #: ( ) _____________
Contact’s email address: _______________________________
Occupation of Contact: _______________________________
Name of initial reporter: _______________________________
Address of initial reporter: _______________________________
_______________________________
This report is: Initial
When did the event happen? (Date) ___/___/____
How many days ago did you first become aware of the event?
Less than or equal to 10 days |
More than 10 days ago |
Date of this report: (mo/day/year): ___/___/_____
Where did this event occur?
Hospital |
Home |
Nursing home |
Outpatient treatment facility |
Outpatient diagnostic facility |
Ambulatory surgical facility |
Other |
Not known |
Not applicable |
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If you checked hospital, where in the hospital did this event occur?
Critical Care |
OR |
Skilled nursing unit in hospital |
Other (specify): |
Not known |
Not applicable |
What outcomes may be attributed to this event (Check all that apply):
Death (date___/___/_____) |
Serious injury |
Potential harm to a health care provider [indicates voluntary report] |
Minor injury to the patient or health care provider [Indicates voluntary report] |
Potential for patient harm [Indicates voluntary report] |
Not known |
Not applicable |
If you checked serious injury, please answer the following 3 questions.
Was intervention required to prevent permanent impairment or damage?
Yes |
No |
Not known |
Not applicable |
Outcomes attributed to serious injury (check all that apply):
Life threatening |
Hospitalization, initial or prolonged |
Congenital anomaly |
Disability |
Other |
Not known |
Not applicable |
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If you checked “Other,” above, please describe the outcome.
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Was there a problem with the device (such as a defect, malfunction, break, etc.)?
Yes |
No |
Not known |
Not applicable |
What problem did the user have (check all that apply):
Device failed (e.g. broke, couldn’t get it to work or stopped working) |
Device malfunction, that is, the device did not do what it was supposed to do |
Device was hard to use |
Other |
Not known |
Not applicable |
Was someone directly “operating” the device at the time of the event?
Yes |
No |
Not known |
Not applicable |
Who was operating the device (check all that apply)?
Doctor |
Nurse |
Allied Health Provider |
Family Member/Visitor |
Patient |
Other |
Not known |
Not applicable |
If you selected “Other,” above, please describe the type of person who was operating the device (not the person’s name).
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Were there other devices being used on the patient at the time of the event that may have caused or contributed to the event?
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Were there other therapies being used on the patient at the time of the event that may have caused or contributed to the event (check all that apply)?
Cardiac Drugs |
Chemo Therapy (date: __________) |
Dialysis (date: __________) |
Hormonal Replacement Therapy |
Immuno Therapy |
Long-Term Antiobiotics |
Prenatal medication |
Other |
No other therapies |
Not known |
Not applicable |
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List other therapies used on the patient at the time of the event that may have caused or contributed to the event:
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Describe the event or problem. Please provide as much detail as possible:
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PATIENT INFORMATION
PLEASE USE A SEPARATE PAGE FOR EACH PERSON INVOLVED.
Patient Identifier (use something that will help you remember who the patient is, but not the patient’s name or SSN):
_____________________________________________________________
Patient’s age: ____________
Days |
Weeks |
Months |
Years |
Date of birth (enter above) |
Not known |
Not applicable |
Patient’s sex:
� Male |
� Female |
� Not known |
� Not applicable |
Patient’s weight: ______________
Ounces |
Pounds |
Kilograms |
Grams |
Not known |
Not applicable |
Patient’s ethnic background (Optional):
American Indian |
Black or African American |
Native Hawaiian or other Pacific Islander |
Asian |
Hispanic or Latino |
White |
Not known |
Not applicable |
Did the patient have any of the following preexisting characteristics that may have contributed to the event (check all that apply.)
Allergies |
Alcohol/drug use |
COPD |
Coronary heart disease |
Diabetes |
Hepatic/renal dysfunction |
Hypertension |
Immuno-compromised |
Morbidly obese |
Pneumonia |
Pregnancy |
Premature infant |
Smoking |
Status post total hysterectomy or salpingioherectomy |
Stroke |
Surgery |
Relevant accident (e.g. Hit head) |
Other |
No |
Not known |
Not applicable |
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Please list the relevant patient allergies. for example, Latex allergy; a particular medication allergy; allergy to a particular material or biomaterial, etc.
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Please describe the relevant accident preceding the event:
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Other characteristics or medical conditions: [Optional]
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Other pertinent patient information:
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DEVICE INFORMATION
PLEASE USE A SEPARATE PAGE FOR EACH DEVICE INVOLVED.
Device manufacturer’s name: _____________________________________________
Device manufacturer’s address: _____________________________________________
_____________________________________________
City: _____________________________________________
State: _____________________________________________
Zip: _____________________________________________
Device brand name: _____________________________________________
Type of device: _____________________________________________
Approximate age of device: _____________________________________________
Device numbers: Please fill in all that are available.
Device serial #: _____________________________________________
Device model #: _____________________________________________
Device lot #: _____________________________________________
Device Catalog #: _____________________________________________
Other device #: _____________________________________________
Expiration Date: _____________________________________________
Yes |
No |
Not known |
Not applicable |
If the device was implanted, give implant date: (mo/day/year) ___/___/_____
If the device was explanted, give explant date: (mo/day/year) ___/___/_____
Yes |
No |
Not known |
Not applicable |
Yes |
No |
Not known |
Not applicable |
Date device was returned to manufacturer: ___/___/___
Manufacturer comments to site:
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Was this a laboratory device? If Yes, please answer the following questions:
Did the problem involve (check all that apply):
1. The reagent?
2. The instrument?
3. Single use test?
4. Something else? (specify)
Is this a recurrent problem with this assay, test kit, or instrument?
1. Yes
2. No
Additional comments
Which of the following problems did you observe? (Check all that apply and include additional comments as needed)
1. Calibration
2. Repeated error message
3. Reproducibility
4. Analytical sensitivity
5. Analytical specificity
6. Quality control
7. Questionable patient results
8. Reagent(s)
9. Inadequate/unclear instructions
for use
10. Poor test/instrument design
11. Performance described in package
insert not met
12. Specimen problems
13. Patient related problems
14. Other (specify)
Product not available to return to manufacturer
9. Discontinued all use of product
10. Not known
11. Not applicable
12. Other (specify):
Additional Comments: ________________
Please describe any follow-up actions below (check all that apply and include additional comments as needed):
1. Repeated assay,
results OK,
reported out
2. Repeated assay, still problems
3. Replaced reagents
4. Opened new lot
5. Manufacturer notified
6. Called for service
7. Product returned to manufacturer
(Date of return: ___/___/____)
Additional Comments
8. Product not available to return to manufacturer
9. Discontinued all use of product
10. Not known
11. Not applicable
12. Other (specify):
Additional Comments:
If this is a tissue or cell product, please fill in the following:
These questions were added to gain more information about tissue and cell products
1. Transplant Product Distinct Identification Code (or other identifiers) ____________________________
No problem was detected with the product.
Product damage, describe________________________
Packaging problem, describe________________________
Product contamination, describe________________________
Labeling problem, describe________________________
Product Irregularity, describe________________________
Other___________________________________________
3. Was the human cell or tissue manipulated following removal from the packaging prior to transplantation?
Yes. Please describe (e.g., stretched, rinsed in saline):
___________________________________________________
No (SKIP TO 4)
Unknown (SKIP TO 4)
4. Was a pre-transplant gram stain of the tissue performed?
Yes, pre-transplant gram stain was performed.
No, pre-transplant gram stain was not performed. (SKIP TO 5)
Do not know (SKIP TO 5 )
Other (Specify) ______________________________________
4a. The gram stain result was:
Positive for organisms: RESULT_______________________
Unknown
Other (Specify) ______________________________________
5. Was a pre-implant culture performed?
Yes, pre-implant culture was performed
No, pre-implant culture was not performed (SKIP to 6)
Unknown (SKIP to 6)
Other (Specify) ______________________________________
5a. The culture showed:
No growth of organisms
Positive growth of organism(s). Identification of organism: ___________________________________________________
Unknown
Other (Specify) ______________________________________
Not known (Skip to 8)
Other (Specify) ______________________________________________
7. Date of Transplant/Infusion _____/____/_____
mm/ dd/ yyyy
8. Were any devices transplanted with the tissue?
Yes (Please provide information in the DEVICE section of the MedSun database)
No
Unknown
Was there a post-transplant adverse event or close call?
Yes, adverse event
Yes, potential adverse event (or close call)
No (Please skip to end to record any additional comments.)
( Check here if there was not an infection-related adverse event and skip to 11.)
Anatomic Site____________________ Date___/____/_______
Results________________________ mm/ dd/ yyyy
Anatomic Site ____________________ Date___/____/_______
Results________________________ mm/ dd/ yyyy
Anatomic Site ____________________ Date___/____/_______
Results________________________ mm/ dd/ yyyy
10b. Other Study Results:
Test ______________ Date___/____/_______ Results________________________
mm/ dd/ yyyy
Test ______________ Date____/____/______ Results________________________
mm/ dd/ yyyy
Test ______________ Date____/____/______ Results________________________
mm/ dd/ yyyy
( Check here if this does not apply. Proceed to 12.)
Allograft malfunction: Describe________________________
Allograft rejection: Describe________________________
Other__________________________________
No intervention
Antibiotics for prophylaxis
Antibiotics for treatment
Required hospitalization
Required prolonged hospitalization for patient already hospitalized
Required additional procedure:
Specify Procedure_______________________
Date Performed: ________________
Required explantation (Specify Date)___/___/____
Required retransplantation (Specify Date)___/___/____
Unknown
Other (Specify) ___________________________________________________
Any Additional Comments:
______________________________________________________________________
TESTS
Please enter all relevant tests/laboratory data.
Test |
Date |
Results |
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| File Type | application/msword |
| File Title | MEDSUN Report |
| Author | Aletha Dixon |
| Last Modified By | DPresley |
| File Modified | 2007-09-11 |
| File Created | 2007-09-10 |